Trial-Specific Baseline Data

Protocol Name Patient Number - Patient Initials  

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Demographics and Trial-Specific Baseline Data 27 Concomitant or Prior Medication Data 27 Medical History Data 29 Investigational Therapy Drug Log 30 Laboratory Data 31 Adverse Event Data 32 Endpoint/Event Assessment Data 35 Clinical Endpoint Committee (CEC) Data 36 Study Termination Data 37 Treatment Randomization Data 38 Quality-of-Life Data 40... 

A similar table may be presented for demographic characteristics. Specific characteristics that are important can vary from study to study, but typical ones include gender, age, race, and baseline data of relevance, e.g., weight, blood pressure, and heart rate. Information concerning the use of concomitant or concurrent medications and evaluations of subject adherence or compliance with the trial s treatment schedule is also typically presented. 

While the use of preclinical disease models offers many advantages, such as the potential for identification of biomarkers for clinical trials and a direct estimation of the therapeutic index, there are also disadvantages to this approach. The disadvantages can include a paucity of historical/baseline data and inherent variability of the model, the technical feasibility of using a particular disease model, the onset/severity of the injury in the animals as this may be different from humans, and the fact that the model may only emulate select aspects of the human pathophysiology of the disease [43], It is important to use behavioral models that have adequate sensitivity and specificity to allow for correlation with morphological and biochemical findings, as in the area of spinal cord injury. 

The protocol should specify what should be recorded directly into the CRF and what will also be recorded in the medical records. The CRF will contain all the pertinent data associated specifically with the clinical trial but some will be repeated in the medical records, for example, the protocol identification number, date of consent, date of commencement of the study, key baseline medical findings, visit dates, start and finish dates of the study drug/placebo or treatment, concurrent medication, adverse events and key efficacy and any unscheduled or scheduled actions or interventions (such as escape medication). Additional information obtained from biopsy reports, radiographs and similar documents will provide confirmation that the data in the CRF are recorded correctly. Monitors, QA auditors and inspectors need to see all the medical records available to the investigator. It is not appropriate to create copies of data from CRFs or checklists derived from medical records and claim that these are source documents. 

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